| The FDA believes that national and international device |
registries in selected product areas are the foundation of
our National Medical Device Postmarket Surveillance System.
by David R. Dills
Sr. Consultant, Regulatory & Compliance, Devices
A registry is broadly defined as a collection of information about individuals, usually focused around a specific diagnosis, condition, or intervention. Individuals may provide information about themselves to a registry on a voluntary basis, either directly or through their physicians. A registry can be sponsored by a government agency, nonprofit organization, health care facility, or private company, and over time can provide researchers and other health care delivery stakeholders with first-hand information about patients, both individually and as a group, which can increase our understanding of that condition. This post places key emphasis on medical device registries and why this topic is becoming increasingly important with FDA and our device manufacturers.
So, Why Medical Device Registries?In 2012, CDRH laid out a strategy to strengthen the nation’s postmarket surveillance system for devices. In 2013, after receiving public input on the 2012 strategy, FDA published an update that described the five major steps the FDA would take to create a National Medical Device Postmarket Surveillance System (MDS):
1. Establish a multi-stakeholder Medical Device Postmarket Surveillance System Planning Board to identify the governance structure, practices, policies, procedures, methods and business model(s) necessary to facilitate the creation of a sustainable, integrated medical device postmarket surveillance system.
2. Establish a unique device identification (UDI) system and promote its incorporation into electronic health information.
3. Promote the development of national and international device registries for selected products.
4. Modernize adverse event reporting and analysis.
5. Develop and use new methods for evidence generation, synthesis, and appraisal.
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What does this all translate into going forward? For starters, FDA established a Medical Device Registry Task Force consisting of key stakeholders under CDRH’s Medical Device Epidemiology Network (MDEpiNet) Program. The objectives of the Task Force are to: 1) identify existing registries that may contribute to the system; 2) leverage on-going registry efforts focused on quality improvement, reimbursement, patient-centered outcomes and other activities to best meet the needs of multiple stakeholders; 3) identify priority medical device types for which the establishment of a longitudinal registry is of significant public health importance; 4) define registry governance and data quality practices that promote rigorous design, conduct, analysis, and transparency to meet stakeholder needs; and 5) develop strategies for the use of registries to support premarket approval and clearance.
The FDA believes that national and international device registries in selected product areas are the foundation of our National Medical Device Postmarket Surveillance System. The system could be linked to longitudinal data, such as administrative and claims data, and would employ novel methods for evidence generation, synthesis and appraisal, modernized adverse event reporting and analysis, and would complement existing tools such as Medical Device Reporting (MDR), an enhanced surveillance network of approximately 280 hospitals, possibly even a higher number, (Medical Product Safety Network – MedSun), studies ordered by the FDA for selected devices (Post-Approval Studies and Postmarket Surveillance Studies), FDA research using other data sources (FDA Discretionary Studies), and other tools such as device tracking.
An initial report from the Task Force recommended the creation of a master network of data from each clinical area where devices are used. Such a network would aggregate medical device information from claims data, electronic health records, and registries into a central location. Doing so would make the data easier for regulators, physicians, and patients to use. Sounds good! In addition, a coordinated registries network would give device makers access to information from a more diverse population of patients who have been exposed to devices in various treatment settings. In the months ahead, FDA will receive additional reports from the Task Force that will enrich the national dialogue on the development of registries as a crucial source of data on device performance.
Comment and Take AwayAs a result of these efforts, registries will play a unique and prominent role in medical device surveillance because they can provide additional detailed information about patients, procedures, and devices not routinely collected by electronic health records, administrative or claims data. For this reason, registries will serve a critical, complementary role in medical device postmarket surveillance, even as UDI becomes more routinely incorporated into electronic health information. However, I caution against the creation of individual registries to meet the needs of a specific manufacturer or a specific product. Historically, this has been neither efficient nor economical and it is impractical and unnecessary to have registries for every medical device type. Instead, targeted registry efforts should be based on wide stakeholder input and support and should focus on selected areas of high importance as reflected by a large public health need, patient exposure, uncertain long-term or real-world device performance, or societal cost. Certainly a coordinated registries network will provide tangible benefits for patients and physicians but also provide our device makers access to information from a more diverse population of patients who have been exposed to devices in various treatment settings. Sounds like a winner indeed!
David R. Dills serves as senior regulatory affairs and compliance consultant for NovusLife. David provides consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent for clients, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification. He may be reached at email@example.com.